Clinical Operations Manager

Clinical Operations Manager


Position Summary:


Management of clinical research projects, personnel and consultants.  Responsible for organizing, communicating, managing and evaluating team objectives for clinical studies.  Responsible for the day-to-day operations of the Research Center.




Duties and Responsibilities:


  • Management of Clinical research projects, personnel, consultants and Research Clinic.
  • Partner with management to develop corporate and department goals; and work with staff and clinical sites to achieve goals within the expected timeline.
  • Manage of clinical studies being conducted in the Research Clinic and at clinical sites, participating in the design and initiation to ensure clinical relevance and clinical excellence.
  • Develop and implement Standards of Practice for on-site clinic and clinical trials.
  • Streamline and continuously update paperwork needed for on-site clinic and clinical trials.
  • Coordinate the efforts of internal and external resources to ensure expedient patient recruitment while in compliance with the regulatory boards.
  • Provide timely updates and status reports to clinical team on regular basis
  • Develop and maintain strategic relationships with third party vendors, organizations, and key opinion leaders.
  • Manage research projects and any other project related tasks within timelines based on regulatory submission requirements, marketing goals and scientific meeting deadlines.
  • Prepare study documents (e.g. protocols; informed consent, subject instructions, CRFs, etc.).
  • Manage IRB submissions and communications.
  • Performing study initiation, training of on-site personnel, interim monitoring and study close-out.
  • Ensure studies are conducted in accordance with SOPs, GCP and ICH Good Clinical Practice guidelines.
  • Oversee the maintenance of the study and site specific regulatory documentation (binders).
  • Assist in write up of regulatory documents, study reports, abstracts and manuscripts.
  • Maintain study tracking tools (study milestones, site payments, subject payments, vendors etc.)
  • Other duties as assigned

Position Requirements:

  • B.Sc. in the life sciences or related field with a minimum of 6-Plus years of experience, or equivalent, in the medical device industry/other highly regulated/high tech industry
  • Knowledge of GCP guidelines, medical terminology and clinical trial processes required.
  • Strong computer skills (excel, power point etc.).
  • Broad knowledge of the laser and light based medical device aesthetic market players and products preferred
  • Demonstrated history of successful project leadership
  • Ability to lead and work collaboratively with cross-functional teams
  • Strong organizational skills with attention to details.
  • Ability to work in a fast paced/demanding environment
  • Excellent oral and written communication skills
  • Problem solver, excellent analytical skills

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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